At the latest HSA briefing held on 28 Feb 2018, it was announced that a revised regulation is targeted to be rolled out in June or July 2018.
With the revised regulation, here are the following changes:
For Changes in Regulatory Requirements for Class A Medical Device (MD) after the revised regulation is implemented
All Class A MD (includes Sterile) are not required for registration.
Only notification is required and dealers have to do it by listing them in Class A database, prior to import/supply
For solely Class A MD dealers, only DoC to QMS is required. 3rd Party Audit and
Certification is not required anymore. QMSCAD will be obsoleted too.
The draft will be published for comment in March/April.
For Changes in Regulatory Requirements for Class B MD after the revised regulation is implemented
There will be no EBR-1 and EBR-2, they will be lumped under Immediate Class B Evaluation Route (IBR).
Requirement for IBR include:
No safety issues globally and with 2 reference regulatory agencies approval
No safety issues globally with 1 reference agency and 3 years marketing history.
For Standalone Mobile Medical Device Applications
Both Class B and Class C of Standalone Mobile MD will qualify for Immediate Registration Route if the device is reviewed and approved by 1 reference regulatory agencies and no safety issues globally
For Devices for Wellness Purpose
Telehealth Products that is not intended for medical purposes has to indicate "intended for wellness purpose"
For Devices for Aesthetic Purpose
HSA is focusing their regulatory oversight on high risk devices under this category.
High risk devices are those
with known or reported serious adverse events globally
pose comparable risks to other regulated medical devices (e.g. foreseeable hazards)
List of high risk devices intended for aesthetics-related purposes only that will be regulated as medical devices
Any implant for the modification or fixation of any body part (e.g breast implant, gluteal implant)
Any injectable dermal or mucous membrane filler (e.g. soft tissue fillers, wrinkle fillers)
Any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means. (e.g. liposuction devices)
Devices intended for aesthetic-related purposes that also have medical claims are already regulated as medical devices.
Hence the devices in the positive list are currently subject to MD regulatory controls.
Where devices intended solely for aesthetics-related purpose are not within the high risk list of devices to be regulated as medical devices (cryolipolysis equipment, laser devices for skin tightening)
Some of these devices will still be subject to other local regulatory controls (e.g. NEA controls) Where applicable
No impediment to market access
Operational details on any follow-up actions required from dealers will be communicated at a later date.
For Trained User Only (TUO) MD
This category will be introduced due to a Medical Device Reporting (MDR) that happened in the United States of America where deaths were reported. The device involved was meant to be used by non-doctors.
The manufacturers will have to indicate the intended user and determine if training is required for the user to become a "trained user".
Unlike Professional Use Only Devices, TUO will not have additional registration condition.
For Change Notification
An updated guidance which include industry feedback from the previous focus group session will be published for public consultation.
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